Kornimate/medical-research-clean huggingface dataset:
pharmacogenetics informed tricyclic antidepressant dosing (pita)

Conditions: Depressive Disorder, Major

Summary: tricyclic antidepressants (tca's) are the cornerstone of treatment for patients with severe major depressive disorder (smdd). current dosing is guided by repeated measurements of blood levels. compared to patients with a normal metabolization function, for those with increased cyp450 enzyme activity it takes longer to reach a therapeutic drug level. the consequent delay of drug efficacy is associated with a prolonged treatment period, increased risk of suicidal behaviour and eventually lower remission rates. for those with reduced cyp450 activity higher rates of side effects are expected. an innovative tca dosing strategy, taking the genetic variants of cyp2d6 and cyp2c19 into account may help to reduce the above mentioned problems. up till now, the current guidelines for cyp450 pharmacogenetics based tca dosing have not been systematically evaluated for effectiveness and cost-effectiveness in larger groups of patients. such evaluation is necessary before broad implementation of these guidelines can be advocated. in the present study 200 patients with smdd who are treated with nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based both on cyp450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). we hypothesize that genotype informed dosing results in faster attainment of therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels of health- and working related costs.


Eligibility criteria:
inclusion criteria: patients are in- and outpatients, having a primary diagnosis of severe major depressive disorder (scid-i diagnosis in agreement with dsm-5 criteria and a hamilton rating scale for depression score ≥ 19 (ham-d-17-item version), aged 18-65 years, who, according to their physician, are eligible for treatment with a tca (nortriptyline (nor), clomipramine (clomi) or imipramine (imi)). the choice of the specific tca is at the discretion of the physician in attendance. exclusion criteria: 1. psychotic depression 2. bipolar i or ii disorder. 3. schizophrenia or other primary psychotic disorder. 4. drug or alcohol dependence in the past 3 months. 5. mental retardation (iq \< 80). 6. for women: pregnancy or possibility for pregnancy without adequate contraceptive measures. 7. breastfeeding. 8. serious medical illness affecting the cns, including but not restricted to m parkinson, sle, brain tumour, cva. 9. relevant medical illness as contra-indication for tca use, such as recent myocardial infarction. 10. other drugs influencing the pharmacokinetics of the tcas as based on a list of interacting drugs. in case of psychotropic co-medication only a benzodiazepine in a dose equivalent up to 4 mg lorazepam will be allowed.

Keywords: pharmacogenetics antidepressive agents
effects of low protein diet in preventing the progression of chronic kidney disease(ckd)---a prospective study

Conditions: Renal Insufficiency, Chronic

Summary: the purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (ckd , stage 2 to 5).

dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(ckd), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of ckd and proteinuria, but the effects of the low protein diet on renal failure progression rate remain to be determined.the aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of ckd. this is a prospective study, 100 patients who meet inclusion and exclusion criteria will be included. the changes of glomerular filtration rate in ckd and time to renal replacement will be evaluated after 1 year treatment.

Eligibility criteria:
inclusion criteria: patients with chronic kidney disease in stage 2 to 5 (gfr\<60 ml/min/1.73m2) receiving conservative treatment for ckd exclusion criteria: none

Keywords: renal insufficiency, chronic diet, protein-restricted
perioperative salivary alpha-amylase as a predictor of delirium after lower extremity vascular bypass surgery

Conditions: Salivary Alpha-amylase; Delirium; Lower Extremity; Vascular Bypass Surgery

Summary: the aim of this study is to evaluate the role of salivary alpha-amylase as a predictor biomarker of pod in elderly patients undergoing limb bypass surgery.

delirium is a neuropsychiatric syndrome that is characterized by the sudden onset of altered awareness, decreased ability to maintain attention, and disorders of the mental process. the pathophysiology of postoperative delirium (pod) is related to postoperative neuroinflammation. biomarkers not only indicate a certain pathological state, but also provide information about disease activity and progression. although several biomarkers are reported to predict pod, biomarkers with high sensitivity and specificity are still lacking. biochemical parameters associated with complement cascade (c3a, c3, c5a) and inflammatory response (il-17a, il-33, e-selectin, mmp9) were involved in neurocognitive regulation. salivary alpha amylase (saa) enzyme is one of the most important enzyme compositions in the saliva that accounts for 40% to 50% of the total salivary proteins, and most of it is secreted from the parotid gland. saa is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years. * both sexes. * american society of anesthesiologists (asa) physical status iii. * undergoing lower extremity vascular surgery under general anesthesia. exclusion criteria: * patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs). * inability to communicate. * history of psychiatric diseases or previous stroke * previous history of pod. * those with smoking and drinking habits. * pregnant female.
diagnostic performance of chest computed tomography scan in patients aged 65 and over presenting to emergency room with acute dyspnea

Conditions: Dyspnea

Summary: in acute dyspnea, the use of chest radiography is frequent and not very contributive, especially in the elderly patients. however, early diagnosis of the cause of dyspnea in the ed is associated with a better prognosis, in particular for the identification of an infectious or cardiac origin. chest ct has already shown better diagnostic performances than conventional radiography in several pathologies such as low respiratory infection, and the development of so-called "low dose" scans allows to limit the irradiation during this examination. the investigators aim to conduct a diagnostic study comparing non-injected chest ct-scan and conventional chest radiography in patients older than 65 presenting in the ed with acute dyspnea to assess whether ct-scan improves diagnosis.

patients of 65 years and older presenting to the emergency department with acute dyspnea and for whom a chest radiography is mandatory will be screened for inclusion. if the inclusion criteria are met and in the absence of non-inclusion criteria, free and informed oral consent will be sought. once the patient is included, management by the emergency physician will be routine. a non-injected chest ct scan will be requested to the emergency radiology department in addition to the chest radiography. as a result, an x-ray and then a ct scan will be performed in each patient. 3 diagnoses will be collected: 1. by the emergency physician in charge of the patient, after the chest x-ray and before the ct scan (diagu1) 2. by the emergency physician in charge of the patient, after the results of the scan (diagu2) 3. by an adjudication committee after review of the medical file (diagexpert) a comparison will be made between the 3 diagnoses.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 65 years * acute dyspnea (\< 1 week) * prescription of a chest x-ray * oral free and informed consent of the patient after information and delivery of the information note * patient affiliated to a social security system exclusion criteria: * inability to lie down * chest imaging done within the last 7 days * indication to perform a thoracic scan * patient under guardianship or curatorship * patient deprived of liberty, pregnant woman * participation in other interventional research

Keywords: dyspnea ed chest ct-scan
safety and efficacy of topical tolasure on skin punch biopsies in healthy participants

Conditions: Wound Healing

Summary: tolasure is a topical gel for the promotion of wound healing. this phase i study will assess the safety, tolerability and clinical effect of tolasure when applied to skin wounds created by punch biopsy in healthy participants. a total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of tolasure.


Eligibility criteria:
inclusion criteria: * healthy males and females \> 18 years of age * health history review * physical exam * blood and urine clinical chemistries * pregnancy test * drug screen exclusion criteria: * acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis) * prone to keloids or hypertrophic scarring * topical or systemic antibiotics within 4 weeks of study enrollment * subjects with mental illnesses * diagnosed with diabetes type i/ii * surgery within the previous 3 months (except for minor cosmetic or dental procedures) * history of severe vitamin or mineral deficiency * history of drug or alcohol abuse (as defined by the investigator) * smoking/vaping * hiv/aids * consistently taking steroids and/or non-steroidal anti-inflammatory drugs * cancer diagnosis in the last year * currently receiving chemotherapy or radiation * women who are pregnant, nursing or planning a pregnancy * hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields * symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study * treatment with any investigational agent within one month before treatment application for this trial * unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule * other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment

Keywords: healthy participants skin dermal biopsy
hypoplastic left heart syndrome: subendocardial viability after norwood palliation

Conditions: Hypoplastic Left Heart Syndrome

Summary: this project has several objectives ranging from clinical data analysis to computational simulations as listed below: 1. retrospective review of all patients with hlhs treated surgically and followed medically at the irccs policlinico san donato aiming to assess the sevr after each step of norwood palliation to analyze its influences on: * mortality; * occurrence of adverse events; * outcome of the three-staged palliation; 2. creation of a prospective registry that will enroll all patients surgically treated for hlhs at the irccs policlinico san donato.


Eligibility criteria:
inclusion criteria: * pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the norwood palliation at the irccs policlinico san donato. exclusion criteria: * patients with any type of atrioventricular discordance. * pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the norwood palliation at the irccs policlinico san donato before march 2019.
cross sectional area of umbilical cord versus hadlock's formula in prediction of neonatal birth weight

Conditions: Birth Weight; Fetal Body Weight

Summary: ultrasound measurement of cross sectional area of umbilical cord might offer advantage over hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality.

umbilical cord is a vital structure of maternal-fetal life that can be used to evaluate pregnancy outcomes. in the past, sonographic investigations of the umbilical cord were limited to identification of the number of vessels and doppler evaluation of the blood flow. various formulas have developed to calculate estimated fetal weight (efw) using fetal biometry. while it is being accurate to a degree, they are associated with error especially with extreme birth weight. in this study using the ultrasound to look for a relation between the umbilical cord cross sectional area and estimated birth weight, as it's easy to use and readily available, comparing the estimated birth weight obtained by this method with that of hadlock's formula measures at term gestation. trying to prove that the umbilical cord area formula might gave advocacy for future usage for birth weight prediction.

Eligibility criteria:
inclusion criteria: * pregnant women with: * age: 18-35 years. * singleton living fetus. * term gestation (37wks_ 41wks+6days). (spong , 2013). * admitted at labor room or prepared for caesarean section exclusion criteria: * o intrauterine dead fetus (iufd). * structurally malformed fetus or umbilical cord (single umbilical artery; sua). * multiple pregnancies. * oligohydraminos (afi \ 25 cm or dvp \> 8 cm) (morteza et al., 2018). * uterine fibroid. * abnormal doppler flowmetry of umbilical artery. * maternal diseases (diabetes mellitus, hypertensive disorders, renal diseases, ischemic heart diseases), history of drug intake (antihypertensive, antiepileptic, oral hypoglycemic drugs).

Keywords: birth weight hadlock's formula cross sectional area of umbilical cord umbilical cord fetal biometry
liquiband® exceed™ and liquiband® rapid™ for general surgery procedures

Conditions: Surgical Wound

Summary: the purpose of this post market study is to evaluate the performance and safety of liquiband® exceed™ and liquiband® rapid™ for closure of surgical incisions associated with abdominal surgery.

liquiband® exceed™ and liquiband® rapid™ are the "study" devices. the study devices are an adhesive used to close surgical wounds. when the adhesive is applied to the skin, it polymerizes (forms a chemical bond) within minutes due to the moisture on the skin's surface and allows the wound edges to remain in the correct position. the use of the study devices are not "investigational" (experimental) because it is already cleared for doctors to use for surgical wound closure in the united states of america. in this study, liquiband® exceed™ and liquiband® rapid™ will be used to close surgical wounds following general abdominal surgery. subjects will be followed up for 14-days post surgery, and safety and performance of the study device will be evaluated.

Eligibility criteria:
inclusion criteria: patients who meet all of these criteria at time of enrollment may be included in the investigation: 1. subject is ≥ 18 years of age 2. subject is to undergo general abdominal surgery 3. planned incision(s) are expected to be 4cm or greater in length 4. subject is willing and able to comply with the protocol and follow up period 5. subject is willing and able to give written informed consent exclusion criteria: patients who meet any one of these criteria will be excluded from the study: 1. subject is pregnant or nursing 2. subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal. 3. subject has a sensitivity to cyanoacrylates or formaldehyde 4. subject has a known sensitivity to topical skin adhesives 5. subject has active or potential infection at the surgical site 6. subject has a history of keloid formation 7. subject has a known vitamin c or zinc deficiency 8. subject has a connective tissue disorder 9. subject has uncontrolled diabetes mellitus

Keywords: topical skin adhesives, cyanoacrylate liquiband exceed wound closure liquiband rapid
prospective observational clinical follow-up of euromi biosciences pre-filled silicone gel breast implants

Conditions: Breast Implant Rupture; Breast Implant; Complications

Summary: prospective observational clinical follow-up of euromi biosciences silicone gel-filled breast implants - post-market clinical investigation - elegant


Eligibility criteria:
inclusion criteria: * female; * 18 years old and above, and under 60 years old; * has approved and signed the informed consent form; * eligible to receive at least one euromi biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery; * willing to be followed up for a period of 10 years. exclusion criteria: * informed pregnancy or breastfeeding at the time of inclusion * known hypersensitivity and / or allergy to silicone; * not understanding or not accepting the risks of further surgeries during follow-up; * body mass index \> 40 kg/m²; * diabetes * hba1c levels \> 7,5%; * history of repeated failure with the implantation of similar implants; * tissue or fat insufficiency; * progressive breast cancer large tumours (\>5 cm), late cancer stage and deep tumours; * grossly positive axillary involvement / or chest wall involvement; * high risk of cancer recurrence; * tissue damage in the implant area due to irradiation of the thoracic wall; * pre-existing pathology in the implant area; * general infection or infection in the implant area; * medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications; * history or presence of an autoimmune disease; * immunocompromised; * history or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin/tissue / microwave diathermy / or steroids; * medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent; * concomitantly part of another interventional clinical trial. * under supervision or legal guardianship * deprived of liberty by a judicial or administrative decision * not affiliated to health insurance system or is a beneficiary of such coverage
integrated behavioral healthcare for youth with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).


Eligibility criteria:
inclusion criteria: 1. type 1 diabetes diagnosed for one year or more 2. latino or black ethnicity/race 3. speak and read english or spanish 4. eligibility for medicaid exclusion criteria: 1. significant developmental disability 2. serious psychiatric disorder 3. another serious chronic illness
short daily versus conventional hemodialysis for covid-19 patients

Conditions: COVID-19

Summary: treatment of dialysis patients involved with covid-19 with short daily hemodialysis has been supposed to improve short term outcome. it is unclear if short daily dialysis would optimize mortality or icu admission in routine dialysis patients with covid-19. also the potential variants according with worse outcomes remain to be fully elucidated.

investigators undertook a randomized trial in esrd patients infected with covid-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and icu admission in one weak period and; 2) the potential effective variants in worst outcome. . paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in june 2021 for registration . the protocol for this trial and supporting consort checklist are available. the sbmu ethics board approved the study and all amendments. the study was conducted according to the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * esrd patients \>3months on hemodialysis admitted for covid-19 exclusion criteria: * esrd patients \<3 months on hemodialysis infected with covid-19

Keywords: dialysis
pioglitazone special drug use surveillance "metabolic syndrome in patients with type 2 diabetes mellitus"

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this survey is to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on long-term pioglitazone (actos tablets) treatment.

this is a special drug use surveillance on long-term use of pioglitazone (actos tablets) in patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters, and to analyze the association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an exploratory setting. participants will be patients with type 2 diabetes mellitus. the planned sample size is 20000. the usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.

Eligibility criteria:
inclusion criteria: * patients must have type 2 diabetes mellitus and have undergone measurements for all of the following parameters to be included in this survey: waist circumference, height, body weight, blood pressure, haemoglobin a1c (hba1c), fasting triglyceride, high-density lipoprotein (hdl)-cholesterol exclusion criteria: * patients meeting any of the following criteria (1) to (5) will be excluded: 1. patients with any contraindications to pioglitazone (actos tablets) treatment as specified below: cardiac failure, history of cardiac failure, severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, serious hepatic dysfunction, serious renal dysfunction, severe infection, perioperative state, serious trauma, history of hypersensitivity to any ingredients of pioglitazone (actos tablets), pregnancy or possible pregnancy 2. patients aged \< 20 or ≥ 75 years 3. patients who currently have or have had any of the following: myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease (including left ventricular hypertrophy with cardiac hypofunction\*), atrial fibrillation, atrial flutter, valvular disease, aortic dissection, cerebral infarction, cerebral hemorrhage (including subarachnoid hemorrhage). (\*reduced cardiac function is roughly defined as having a brain natriuretic peptide \[bnp\] ≥ 40 pg/ml.) 4. patients who have taken pioglitazone (actos tablets) within 3 months before enrollment in this survey 5. patients who have been enrolled in the candesartan cilexetil (blopress) special drug use surveillance "hypertension: survey on metabolic equivalents (mets) (challenge-mets)" at each medical institution.

Keywords: drug therapy